Assyro AI

Purple Book product · Biosimilar 351(k)

Eydenzelt

aflibercept-boav

351(k) BiosimilarBLA 761377RxLicensed CELLTRION, Inc.

At a glance

Oct 02, 2025

Approved

Biosimilar 351(k)

License type

Rx

Marketing

No

Patents listed

Key dates

  1. Approval

    Approval date of this BLA submission.

    Oct 02, 2025

    8 mo ago

  2. Today

Pharmaceutical detail

Strength

2MG/0.05ML

Dosage form

Injection

Route

Intravitreal

Presentation

Pre-Filled Syringe

Center

CDER

License number

1996

Product number

002

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of aflibercept (Eylea)

Patent list (88)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
10,857,231Mar 14, 20224 yr 3 mo agoFDA
7,070,959Jun 16, 20233 yr agoFDA
10,406,226Mar 22, 20262 mo agoFDA
10,464,992Jun 14, 2027in 1 yr 1 moFDA
11,066,458Jun 14, 2027in 1 yr 1 moFDA
11,084,865Jun 14, 2027in 1 yr 1 moFDA
11,732,024Jun 14, 2027in 1 yr 1 moFDA
10,415,055Jun 04, 2028in 2 yrFDA
9,562,238Jun 04, 2028in 2 yrFDA
9,932,605Jun 04, 2028in 2 yrFDA
7,771,997Jul 02, 2028in 2 yr 1 moFDA
9,222,106Jul 02, 2028in 2 yr 1 moFDA
10,130,681Jan 11, 2032in 5 yr 8 moFDA
10,828,345Jan 11, 2032in 5 yr 8 moFDA
10,857,205Jan 11, 2032in 5 yr 8 moFDA
10,888,601Jan 11, 2032in 5 yr 8 moFDA
11,253,572Jan 11, 2032in 5 yr 8 moFDA
11,559,564Jan 11, 2032in 5 yr 8 moFDA
11,707,506Jan 11, 2032in 5 yr 8 moFDA
11,975,045Jan 11, 2032in 5 yr 8 moFDA
11,986,511Jan 11, 2032in 5 yr 8 moFDA
12,268,730Jan 11, 2032in 5 yr 8 moFDA
9,669,069Jan 11, 2032in 5 yr 8 moFDA
9,254,338May 22, 2032in 6 yr 1 moFDA
11,332,771Mar 14, 2034in 7 yr 11 moFDA
11,970,724Mar 14, 2034in 7 yr 11 moFDA
D858,754Sep 03, 2034in 8 yr 4 moFDA
9,315,281Sep 16, 2034in 8 yr 5 moFDA
11,268,109Oct 21, 2035in 9 yr 6 moFDA
11,788,102Oct 21, 2035in 9 yr 6 moFDA
9,816,110Oct 21, 2035in 9 yr 6 moFDA
D906,102Dec 29, 2035in 9 yr 9 moFDA
10,927,342Aug 03, 2036in 10 yr 4 moFDA
11,312,936Aug 03, 2036in 10 yr 4 moFDA
12,221,619Aug 03, 2036in 10 yr 4 moFDA
D934,069Oct 26, 2036in 10 yr 7 moFDA
11,549,154Dec 25, 2036in 10 yr 9 moFDA
10,669,594Feb 12, 2037in 10 yr 10 moFDA
11,918,785Jun 29, 2037in 11 yr 3 moFDA
10,182,969Jul 13, 2037in 11 yr 3 moFDA
D961,376Aug 23, 2037in 11 yr 5 moFDA
D961,377Aug 23, 2037in 11 yr 5 moFDA
11,577,025Oct 06, 2037in 11 yr 6 moFDA
11,680,930Oct 25, 2037in 11 yr 7 moFDA
10,905,786Mar 06, 2038in 11 yr 11 moFDA
10,918,754Mar 06, 2038in 11 yr 11 moFDA
12,116,622May 25, 2038in 12 yr 2 moFDA
11,769,597Aug 15, 2038in 12 yr 5 moFDA
11,433,186Dec 12, 2038in 12 yr 8 moFDA
12,168,036May 10, 2039in 13 yr 1 moFDA
11,103,552May 15, 2039in 13 yr 2 moFDA
10,973,879May 17, 2039in 13 yr 2 moFDA
12,280,093May 17, 2039in 13 yr 2 moFDA
D1,035,436Jul 16, 2039in 13 yr 4 moFDA
D1,042,107Sep 17, 2039in 13 yr 6 moFDA
11,850,407Sep 18, 2039in 13 yr 6 moFDA
D1,047,700Oct 22, 2039in 13 yr 7 moFDA
10,961,500Jan 27, 2040in 13 yr 10 moFDA
11,286,460Jan 27, 2040in 13 yr 10 moFDA
11,555,176Jan 27, 2040in 13 yr 10 moFDA
11,821,001Jan 27, 2040in 13 yr 10 moFDA
11,439,758Jun 04, 2040in 14 yr 2 moFDA
11,478,588Jul 25, 2040in 14 yr 4 moFDA
11,160,918Jul 29, 2040in 14 yr 4 moFDA
11,793,926Jul 29, 2040in 14 yr 4 moFDA
11,053,280Aug 18, 2040in 14 yr 5 moFDA
11,104,715Aug 18, 2040in 14 yr 5 moFDA
11,174,283Aug 18, 2040in 14 yr 5 moFDA
11,186,625Aug 18, 2040in 14 yr 5 moFDA
11,299,532Aug 18, 2040in 14 yr 5 moFDA
11,306,135Aug 18, 2040in 14 yr 5 moFDA
11,459,373Aug 18, 2040in 14 yr 5 moFDA
11,459,374Aug 18, 2040in 14 yr 5 moFDA
11,472,861Aug 18, 2040in 14 yr 5 moFDA
11,485,770Aug 18, 2040in 14 yr 5 moFDA
11,505,593Aug 18, 2040in 14 yr 5 moFDA
11,535,663Aug 18, 2040in 14 yr 5 moFDA
11,542,317Aug 18, 2040in 14 yr 5 moFDA
11,548,932Aug 18, 2040in 14 yr 5 moFDA
11,649,273Aug 18, 2040in 14 yr 5 moFDA
11,732,025Aug 18, 2040in 14 yr 5 moFDA
11,753,459Aug 18, 2040in 14 yr 5 moFDA
12,054,533Aug 18, 2040in 14 yr 5 moFDA
12,077,570Aug 18, 2040in 14 yr 5 moFDA
12,202,883Aug 18, 2040in 14 yr 5 moFDA
11,525,833Nov 29, 2040in 14 yr 8 moFDA
12,282,004Dec 09, 2041in 15 yr 9 moFDA
12,163,122May 10, 2042in 16 yr 2 moFDA

Taxonomy and ontology

10 terms

center

Center for Drug Evaluation and Research

center · CDER

application pathway

Biologics License Application

blaNumber · BLA

license type

351(k) Biosimilar

blaType · 351(k) Biosimilar

application pathway

Section 351(k) Biosimilar or Interchangeable

blaType · 351(k)

product role

Biosimilar

blaType · Biosimilar

marketing status

Prescription

marketingStatus · Rx

licensure status

Licensed

licensure · Licensed

dosage form

Injection

dosageForm · Injection

source kind

Monthly Download

sourceKind · monthly_download

patent status

No Patent List Provided

patentListProvided · No patent list

  • Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
  • Food and Drug Administrationsource forMonthly Download
  • Biologics License Applicationparent ofSection 351(a) Biologic
  • Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
  • Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
  • Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable

Source provenance

Source kind · Monthly download
Checked May 28, 2026
FDA release · April 2026
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.